ARIX Femur Nail System

GUDID 08800089430147

Jeil Medical Corporation

Femur intramedullary nail

• Primary Device ID: 08800089430147
• NIH Device Record Key: 56dd7431-6477-4282-823c-f0d5e0e9caf3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ARIX Femur Nail System
• Version Model Number: SPFN-0340-10L-30
• Company DUNS: 688811603
• Company Name: Jeil Medical Corporation
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08800089430147 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K242247

FDA Product Code

• HSB: Rod, Fixation, Intramedullary And Accessories

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-05-08
• Device Publish Date: 2025-04-30

On-Brand Devices [ARIX Femur Nail System]

• 08800089457625: PFN-0420-12R-25
• 08800089457618: PFN-0400-12R-25
• 08800089457601: PFN-0280-12R-25
• 08800089457595: PFN-0260-12R-25
• 08800089457588: PFN-0240-12R-25
• 08800089457571: PFN-0220-12R-25
• 08800089457564: PFN-0440-11R-30
• 08800089457557: PFN-0420-11R-30
• 08800089457540: PFN-0400-11R-30
• 08800089457533: PFN-0280-11R-30
• 08800089457526: PFN-0260-11R-30
• 08800089457519: PFN-0240-11R-30
• 08800089457502: PFN-0220-11R-30
• 08800089457496: PFN-0440-11R-25
• 08800089457489: PFN-0420-11R-25
• 08800089457472: PFN-0400-11R-25
• 08800089457465: PFN-0280-11R-25
• 08800089457458: PFN-0260-11R-25
• 08800089457441: PFN-0240-11R-25
• 08800089457434: PFN-0220-11R-25
• 08800089457427: PFN-0440-10R-30
• 08800089457410: PFN-0420-10R-30
• 08800089457403: PFN-0400-10R-30
• 08800089457397: PFN-0280-10R-30
• 08800089457380: PFN-0260-10R-30
• 08800089457373: PFN-0240-10R-30
• 08800089457366: PFN-0220-10R-30
• 08800089457359: PFN-0440-10R-25
• 08800089457342: PFN-0420-10R-25
• 08800089457335: PFN-0400-10R-25
• 08800089457328: PFN-0280-10R-25
• 08800089457311: PFN-0260-10R-25
• 08800089457304: PFN-0240-10R-25
• 08800089457298: PFN-0220-10R-25
• 08800089456383: SPFN-0220-11R-30
• 08800089456376: SPFN-0440-11R-25
• 08800089456369: SPFN-0420-11R-25
• 08800089456352: SPFN-0400-11R-25
• 08800089456345: SPFN-0280-11R-25
• 08800089456338: SPFN-0260-11R-25
• 08800089456321: SPFN-0240-11R-25
• 08800089456314: SPFN-0220-11R-25
• 08800089456307: SPFN-0440-10R-30
• 08800089456291: SPFN-0420-10R-30
• 08800089456284: SPFN-0400-10R-30
• 08800089456277: SPFN-0280-10R-30
• 08800089456260: SPFN-0260-10R-30
• 08800089456253: SPFN-0240-10R-30
• 08800089456246: SPFN-0220-10R-30
• 08800089456239: SPFN-0440-10R-25